Clinical Trial: Laparoscopic Versus Robot-assisted Inguinal Hernia Repair: A Single Institution Randomized Controlled Trial

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Laparoscopic Versus Robot-assisted Inguinal Hernia Repair: The Immediate, Intermediate, and Long Term Outcome Differences. A Single Institution Randomized Controlled Trial

Brief Summary: Randomized trial to compare outcomes of laparoscopic and robot assisted inguinal hernia repair.

Detailed Summary: Inguinal hernia repair is a very common surgical operation. Both laparoscopic and robot-assisted operations are considered acceptable. However, there is no clear indication for a particular approach. No prospective trial has been conducted so far to establish superiority of one approach over the other. The Investigator believes each approach has unique characteristics and may offer advantages over the other in the right population group. The Investigator will randomly assign patients in two arms according to the surgical approach, whether laparoscopic or robot-assisted. The Investigator will collect preoperative characteristics, intraoperative variables, and postoperative outcomes. The Investigator will compare all variables to establish differences between the two groups.
Sponsor: University of Florida

Current Primary Outcome: Operative time [ Time Frame: Immediate perioperative time ]

Time from start to finish of procedure, procedure start and stop times as recorded by anesthesia.


Original Primary Outcome: Same as current

Current Secondary Outcome: Postoperative pain score [ Time Frame: Until 5 year postoperative ]

Abdominal pain at rest and on moving (recumbent to the upright position), will be assessed using 0-10 Numeric Pain Rating Scale preoperatively (baseline), and at 24 hours, 30 days, one and five years postoperatively.


Original Secondary Outcome: Same as current

Information By: University of Florida

Dates:
Date Received: April 25, 2017
Date Started: May 2017
Date Completion: June 2023
Last Updated: May 3, 2017
Last Verified: May 2017